PHILIPS FR2 3-Lead ECG, IEC

GUDID 00884838049963

FR2 ECG Assessment Module

PHILIPS ELECTRONICS NORTH AMERICA CORPORATION

Electrocardiographic lead set, reusable
Primary Device ID00884838049963
NIH Device Record Key96af4541-11cb-4061-be53-160be4ced8e8
Commercial Distribution Discontinuation2014-12-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NamePHILIPS FR2 3-Lead ECG, IEC
Version Model NumberM3874A
Company DUNS079503890
Company NamePHILIPS ELECTRONICS NORTH AMERICA CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838049963 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MKJAutomated External Defibrillators (Non-Wearable)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-24

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